PET-detected Myocardial Inflammation is a Characteristic of Cardiac Sarcoid But Not of ARVC (NCT02989480) | Clinical Trial Compass
UnknownNot Applicable
PET-detected Myocardial Inflammation is a Characteristic of Cardiac Sarcoid But Not of ARVC
United Kingdom20 participantsStarted 2015-08
Plain-language summary
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare condition in which the heart muscle cells especially of the main pumping chamber (the 'ventricle') is replaced by fat and scar tissue. Sarcoidosis is a condition that can affect many organs but when it affects the heart patches of inflammation can result in scarring, especially of the ventricles. Both conditions can cause dangerous heart rhythms and sudden death. Sarcoidosis can be treated with inflammation suppressing treatment (steroids), as well as pacemakers and implantable defibrillators which shock the heart back to normal rhythm. ARVC is usually treated with implantable defibrillators. The diagnosis of either condition can be difficult and indeed distinguishing the two can be extremely challenging. Increasingly nuclear scans (PET) are used to identify inflammation in the heart in patients suspected of having cardiac sarcoid. It is not known whether patients with ARVC have abnormal PET scans.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Twenty patients from the age of 18-70 will be studied. We will include 10 patients with cardiac sarcoidosis diagnosed according to the Japanese Ministry of Health and Welfare criteria. All patients will have histologically proven sarcoidosis (cardiac biopsy not mandatory) and no other potential cardiac disease. They will have no family history of cardiomyopathy. We will also study 10 patients with ARVC diagnosed according to the Task Force criteria with in addition either a positive family history for the condition or harbour a known pathological mutation associated with it.
Exclusion Criteria:
* patients outside the age limit defined above and those who do not fulfil our inclusion criteria for either cardiac sarcoidosis or ARVC will be excluded.
* unwillingness to participate
* patients with any contraindication to MR scanning
* pregnant or breast feeding women
* diabetes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Myocardial inflammation or fibrosis by cardiac MRI and PET CT